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Effectiveness and Safety of Single Lower Limb Rehabilitation Training Robot in Stroke Patients With Hemiplegia

Primary Purpose

Hemiplegia

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
litestepper single lower limb rehabilitation training robot
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiplegia focused on measuring hemiplegia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • understand the whole process of the experiment, voluntarily participate and sign the informed consent;

    • 18-75 years old for both sexes;

      • Stable vital signs, stable condition, tolerance to low-intensity sitting and standing training;

        ④ Weight ≤ 100kg, height 1.50M ~ 1.90m;

        ⑤ Patients with stroke hemiplegia diagnosed as the first onset, including cerebral infarction and intracerebral hemorrhage, the course of disease is within one month after the onset;

        ⑥ One level of sitting or standing balance, able to wear a single lower limb rehabilitation training robot with the help of medical staff;

        ⑦ The passive range of motion of hip and knee is not significantly limited, and the passive range of ankle can be kept in neutral position.

Exclusion Criteria:

  • The range of motion of the joint is severely limited and the walking movement is limited;

    • Skin injury or infection of the lower limb in contact with the robot;

      • History of unstable angina pectoris, severe arrhythmia and other heart diseases;

        ④ History of severe chronic obstructive pulmonary disease;

        ⑤ Other contraindications or complications that may affect walking training;

        ⑥ Pregnant women, women preparing for pregnancy or lactation;

        ⑦ Those who participated in any clinical trial within 1 month before enrollment;

        ⑧ Other circumstances that the researcher believes cannot participate in the clinical trial.

Sites / Locations

  • 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Robot in lower limb motor function training of stroke patients with hemiplegia

Arm Description

Test equipment: litestepper single lower limb rehabilitation training robot Device type: Class II medical device

Outcomes

Primary Outcome Measures

The Berg balance scale
Berg balance scale .The highest score is 56 points and the lowest score is 0 points. The higher the score, the stronger the balance ability. A score of less than 40 indicates a risk of falling.

Secondary Outcome Measures

Full Information

First Posted
March 31, 2022
Last Updated
August 9, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT05360017
Brief Title
Effectiveness and Safety of Single Lower Limb Rehabilitation Training Robot in Stroke Patients With Hemiplegia
Official Title
A Clinical Trial to Evaluate the Effectiveness and Safety of Single Lower Limb Rehabilitation Training Robot in Lower Limb Motor Function Training of Stroke Patients With Hemiplegia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
December 2, 2021 (Actual)
Primary Completion Date
June 20, 2022 (Actual)
Study Completion Date
June 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This trial is a multi center, randomized, controlled, excellent effect, open and loading trial design. The subjects are randomly assigned to the experimental group and the control group. The experimental group adopts litestepper single lower limb rehabilitation training robot walking training on the basis of routine rehabilitation management of stroke patients with hemiplegia, walking training once a day, 40 ± 5 minutes each time; The control group was treated with routine rehabilitation management of stroke patients with hemiplegia. The trial was an open design. Both researchers and subjects knew the treatment allocation and conducted three evaluations within 21 days to evaluate the effectiveness and safety of litestepper single lower limb rehabilitation training robot in the training of lower limb motor function of stroke patients with hemiplegia.
Detailed Description
By collecting the movement gait information of the patient's healthy side limb, judging the patient's movement intention, analyzing and learning the gait characteristics of the patient's healthy side, so as to drive the movement of the single lower limb rehabilitation training robot and drive the patient's affected side limb to carry out the rehabilitation training suitable for the healthy side limb, which can enable the patient to complete the normal walking process and achieve the purpose of auxiliary rehabilitation. Through long-term walking rehabilitation, patients can gradually recover their normal walking gait.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegia
Keywords
hemiplegia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
multicenter, randomized, controlled, excellent effect, open trial design
Masking
None (Open Label)
Allocation
N/A
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Robot in lower limb motor function training of stroke patients with hemiplegia
Arm Type
Experimental
Arm Description
Test equipment: litestepper single lower limb rehabilitation training robot Device type: Class II medical device
Intervention Type
Device
Intervention Name(s)
litestepper single lower limb rehabilitation training robot
Intervention Description
The experimental group adopts litestepper single lower limb rehabilitation training robot walking training on the basis of routine rehabilitation management of stroke patients with hemiplegia, walking training once a day, 40 ± 5 minutes each time; The control group was treated with routine rehabilitation management of stroke patients with hemiplegia. The trial was an open design. Both researchers and subjects knew the treatment allocation and conducted three evaluations within 21 days to evaluate the effectiveness and safety of litestepper single lower limb rehabilitation training robot in the training of lower limb motor function of stroke patients with hemiplegia.
Primary Outcome Measure Information:
Title
The Berg balance scale
Description
Berg balance scale .The highest score is 56 points and the lowest score is 0 points. The higher the score, the stronger the balance ability. A score of less than 40 indicates a risk of falling.
Time Frame
Visit three (Day 21 ± 2 )

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: understand the whole process of the experiment, voluntarily participate and sign the informed consent; 18-75 years old for both sexes; Stable vital signs, stable condition, tolerance to low-intensity sitting and standing training; ④ Weight ≤ 100kg, height 1.50M ~ 1.90m; ⑤ Patients with stroke hemiplegia diagnosed as the first onset, including cerebral infarction and intracerebral hemorrhage, the course of disease is within one month after the onset; ⑥ One level of sitting or standing balance, able to wear a single lower limb rehabilitation training robot with the help of medical staff; ⑦ The passive range of motion of hip and knee is not significantly limited, and the passive range of ankle can be kept in neutral position. Exclusion Criteria: The range of motion of the joint is severely limited and the walking movement is limited; Skin injury or infection of the lower limb in contact with the robot; History of unstable angina pectoris, severe arrhythmia and other heart diseases; ④ History of severe chronic obstructive pulmonary disease; ⑤ Other contraindications or complications that may affect walking training; ⑥ Pregnant women, women preparing for pregnancy or lactation; ⑦ Those who participated in any clinical trial within 1 month before enrollment; ⑧ Other circumstances that the researcher believes cannot participate in the clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying Jin, Master
Organizational Affiliation
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China

12. IPD Sharing Statement

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Effectiveness and Safety of Single Lower Limb Rehabilitation Training Robot in Stroke Patients With Hemiplegia

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